JP2019526300A - Device and method for treating the sides of the nasal cavity - Google Patents

Abstract

The invention disclosed herein generally relates to devices that can modify the nature of nerves. Specifically, the present invention contemplates modifying posterior nasal nerve signal conduction in such a way as to reduce the signal transmitted to the nasal cavity. Reduction or interruption of neural signals results in reduced distal organ activity. Embodiments of the present invention allow increased lateral contact or juxtaposition of a target tissue region having at least one posterior nasal nerve with the end effector surface by lateral and longitudinal translation of the end effector relative to the surgical probe shaft. To do. This improvement in lateral surface contact translates directly into improved patient outcome and patient safety when the end effector is in sufficient contact with the target tissue for subsequent ablation therapy.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of US Provisional Patent Application No. 62 / 350,445 entitled “DEVICES AND METHODS FOR TREATING A LATERF SURFACE OF A NASAL CAVITY” filed on June 15, 2016. The entire disclosure of which is hereby incorporated by reference in its entirety for all purposes.

Background of the Invention Referring to FIG. 1, the nose N provides several important features for the body shown on both sides of the sagittal plane SP of the body. In addition to the sense of smell, the nose provides an airway for breathing. Inhalation is warmed, filtered, and humidified by the nasal mucosa as it passes through the nasal cavity. This supports airway physiology and protects the lower respiratory tract from harmful stimuli in the environment. The airflow is adjusted and corrected by the nasal concha T1, T2, T3. Nasal turbinates T1, T2, and T3 are bone processes that extend inward from the side wall of the nose N toward the nasal septum S and are covered with mucosal tissue. On each side of the nose N, there are three turbinates: upper turbinate T1, middle turbinate T2, and lower turbinate T3. Each turbinate defines a nasal passage, which is a natural body opening or passage leading to the interior of the body. For example, the passage between the upper turbinate T1 and the middle turbinate T2 is the upper nasal passage M1. This is the smallest nasal passage. The middle nasal passage M2 is a passage extending between the middle turbinate T2 and the lower turbinate T3. The middle nasal passage M2 contains a meniscal hiatus with an opening or mouth into the maxilla, frontal, and anterior ethmoid sinus. The passage below the lower turbinate T3 is the largest nasal passage, namely the lower nasal passage M3 (not visible in FIG. 1). A conduit, known as the nasolacrimal duct, drains tears from the eye through an opening located in the lower nasal passage into the nose. These turbinates T1, T2, and T3 serve to increase the internal surface area of the nose N and impart warmth and moisture to the air inhaled through the nose N. Mucosal tissue covering the nasal turbinates can become congested or swollen or substantially depleted and contracted in response to changes in physiological or environmental conditions. This constriction and swelling of the turbinates modifies the airflow from laminar to very turbulent. Turbulent air spends more time in the nose as it passes filtered, humidified, and warmed. This process requires the proper functioning of multiple systems, including mucosal vasculature, autonomic nerves, and sensory nerves.

FIG. 2 is an internal view of the nasal nasal cavity of FIG. 1, showing a portion of the nasal structure and nasal nerve anatomy. Regarding orientation, the lateral nasal cavity wall W, nose N, nostril NO, and upper lip UL are shown. Upper nasal turbinate T1, middle nasal turbinate T2, and lower nasal turbinate T3 are depicted with a portion of the nasal nerve anatomy indicated by the dashed line. The sphenoid palatal ganglion SG (also known as the wing palatal ganglion, Meckel ganglion, or nasal ganglion) is a parasympathetic ganglion located in the side wall W below a portion of the middle turbinate M2. . The posterior nasal nerve extends from the sphenoid palate ganglion SG. The lateral branches, known as lateral posterior nasal nerves N1, N2, and N3, distribute nerves to the side walls and nasal turbinates T1, T2, T3. The medial branch, known as the medial posterior nasal nerve, distributes the nerve in the septum and is not shown in this figure. These nerves, along with the vasculature and various other nasal structures, help control mucosal responses to various factors, thereby affecting nasal turbinate contraction and swelling and nasal discharge production.
Ideally, these systems maintain a properly functioning nasal environment, however, there are various factors that can lead to debilitating conditions including rhinitis.

  Rhinitis is defined as inflammation of the nasal mucosa or mucosal lining characterized by nasal symptoms, including pruritus, rhinorrhea, nasal congestion, sneezing, and postnasal drip. Rhinitis can occur due to colds or seasonal allergies. However, in some cases, persistent or chronic rhinitis occurs where symptoms persist for a long time. Typically, symptoms are present in some part of the day for most days over a long period of time. Many people suffer from regular and daily symptoms. Severe symptoms can affect work, school, home, and social life.

  Chronic rhinitis is non-allergic (vasomotor), including three types: (1) idiopathic, endocrine, atrophic, occupational and taste rhinitis, and drug-induced rhinitis (drug-induced). Category: rhinitis, (2) allergic rhinitis induced by pollen, fungi, animal dander, dust, and other inhaled allergens, and (3) mixed rhinitis, a combination of non-allergic and allergic rhinitis It becomes.

  Non-allergic rhinitis refers to rhinitis that does not result from allergy. The exact cause of non-allergic rhinitis is unknown, but can occur when blood vessels in the nose expand or dilate and fill the nasal lining with blood and fluid. There are several possible causes for this abnormal dilation or inflammation of blood vessels in the nose. One possibility is that the nerve endings in the nose can be over-responsive to stimulation or triggering. Some common causes of non-allergic rhinitis are: (a) environmental or occupational irritants such as dust, smog, sidestream smoke, or strong odor (eg perfume); (b) exposure in certain occupations (C) weather changes such as temperature or humidity changes, (d) spicy or spicy dishes, or dishes and beverages such as drinking alcoholic beverages, (e) aspirin, ibuprofen (Advil, Motrin) IB, etc.), hypertensive drugs (eg beta blockers), sedatives, antidepressants, oral contraceptives, drugs used to treat erectile dysfunction, and drugs such as overuse of nasal congestion removal sprays, And (f) hormonal changes such as pregnancy, menstruation, use of oral contraceptives, or other hormone status such as hypothyroidism. In many cases, these triggers are difficult or impossible to avoid reaching a chronic health condition.

  Allergic rhinitis can occur subsequently when inhaled by an individual with an immune system sensitized to an allergen, such as pollen or dust, to induce antibody production. These antibodies bind to mast cells that contain mostly histamine. When mast cells are stimulated by allergens, histamine (and other chemicals) are released. This causes itching, swelling, and mucus production. Characteristic physical findings in individuals with allergic rhinitis include conjunctival swelling and erythema, eyelid swelling, inferior eyelid vein stasis, lateral heel over the nose, swollen turbinates, and middle ear exudates. Allergic rhinitis can occur as a local allergy in the nose that is not revealed by an intradermal or blood test for allergies. Thus, many people previously diagnosed with non-allergic rhinitis may actually have local allergic rhinitis.

  Chronic rhinitis can lead to various complications. Sinusitis is the most common complication of chronic rhinitis. The sinuses are spaces filled with small air inside the cheekbones and forehead. The paranasal sinuses create some mucus that flows into the nose through a small pathway. If the nose is blocked or clogged, the sinuses may not drain properly into the nose. This means that mucus in the sinuses can be blocked and more easily infected. Another complication is a nasal polyp. These are soft, non-cancerous (benign) tumors that develop on the lining of the nose or sinuses due to chronic inflammation. Large polyps can block airflow through the nose and make it difficult to breathe. Middle ear infections are another complication of chronic rhinitis that results from increased fluid and nasal congestion. Due to all of these, a common complication is a decrease in quality of life. Chronic rhinitis is devastating and can interfere with daily activities. Work and school productivity can be reduced, and time can be lost to worsening symptoms or examination.

  Medical treatment has been shown to have limited effects for patients with chronic rhinitis. Patients with allergic rhinitis typically avoid the causes of allergies, which can be difficult or impossible, or use daily medications such as antihistamine nasal sprays, antihistamine tablets, and steroid nasal sprays. To be directed. These drugs can be cumbersome and can cause undesirable side effects. Non-allergic rhinitis is more difficult to treat and such treatment depends on causes that may be unknown. Thus, chronic rhinitis patients typically have fewer treatment options.

  One type of procedure is nasal turbinate reduction surgery. As mentioned above, the turbinate serves to warm and humidify the air as it flows through the nose. However, the turbinates expand in chronic rhinitis and block nasal airflow. There are many ways to reduce the size of the turbinates. Surgery is typically called nasal turbinate reduction or turbinate resection. It is important that the turbinates not be over-reduced or completely removed because they can lead to “empty nose syndrome”, which represents a nose that is physiologically impaired by excessive surgical removal of the turbinates in the nose It is. Side effects include chronic mucosal inflammation (which can atrophy the mucosal area), odd and heterogeneous obstruction (often a nuisance of constant or frequent suffocation generated by poor airflow feedback from the nasal mucosa. More severe cases in the nose, pharynx, ear canal, throat, larynx, trachea, including neuropathic pain in the bronchi and lungs. Chronic hoarseness and cough can also occur. This is caused by poorly treated (humidified, warmed, cleaned) air passing through the respiratory system. ENS may also serve as a prerequisite for asthma.

  Even when nasal constriction surgery is performed conservatively, it can have a temporary duration of effect of 1 to 2 years, with complications including mucosal carcass formation, acute pain and swelling, and bone damage. Can bring. In addition, turbinate contraction does not treat the symptoms of rhinorrhea.

  In addition, some rhinitis patients do not respond to treatment. Such patients receive treatment, including antihistamines, topical and systemic steroids, topical anticholinergics, nasal turbinatectomy, and specific immunotherapy (SIT), including subcutaneous (SCIT) and sublingual (SLIT). I give up. For such patients, neurosurgery has been introduced as the final stage of treatment. Golding-Wood first introduced the concept of Vidian nerve amputation as the definitive surgical management for chronic rhinitis in the 1960s. The theoretical basis of this surgery is the imbalance between nasal parasympathetic and sympathetic innervation, and stimulation resulting from goblet cells and mucous glands. The goal of this surgical technique is to prevent this imbalance and reduce nasal discharge. The Vidian nerve connects to the wing palate ganglion inside the wing palate fossa and exits from the skull through the wing tube. In the Vidian nerve amputation procedure, the Vidian nerve was severed to reduce nasal congestion and rhinitis. However, many practitioners have technical difficulties, their transient effectiveness, and transient cheek and dental paralysis, damage to the maxillary nerve (round hole), nasal crust formation, dryness, Vidian nerve amputation due to the onset of bronchial asthma, bleeding, and loss of vision due to autonomic fiber breakage in the Vidian nerve supplying the lacrimal gland and complications such as ophthalmic complications including dry eye Have abandoned.

  Recent studies have shown that selectively blocking the posterior nasal nerve (PNN) in patients with chronic rhinitis improves symptoms while avoiding the morbidity associated with Vidian nerve amputation Yes. The posterior nasal nerve amputation, first developed by Kikawada in 1998 and later modified by Kawamura and Kubo, is an alternative method in which the nerve bundle is selectively cut or cauterized from the butterfly palate. Autonomic and sensory nerve fibers that pass through the hole anatomically branch into the middle and inferior turbinates and are distributed around the nasal mucosal layer. Thus, selective nerve amputation at this time allows physicians to theoretically avoid deleterious surgical complications such as inhibition of tear secretion.

  Ikeda et. A study by al suggests that the effect of anticholinergic drugs on nasal symptoms is similar to that of PNN resection in patients with chronic rhinitis. Based on his study, glandular mucosa acinar cells were significantly reduced after PNN resection. The reduction in glandular cells can be explained by a decrease in the secretion of nerve growth factor or epidermal growth factor, which is regulated by acetylcholine, the major neurotransmitter of the parasympathetic nervous system.

  Chronic rhinitis is a worldwide medical problem with a few successful treatment options with minimal side effects and satisfactory results. Some estimate that 10% to 25% of the world's population suffers from nasal inflammation. It is almost the combined population of the United States and China. Treatment tends to be expensive for our medical system. It is estimated that in 2002, allergic rhinitis alone accounted for $ 11 billion in indirect and direct medical expenses. The addition of non-allergic rhinitis greatly increases this figure. Rhinitis is also particularly problematic because patients can be misdiagnosed and mismanaged by primary care providers, placing additional burdens on the system in absenteeism days for ineffective treatment and ongoing discomfort for the patient. is there. It is important to properly treat these patients in order to reduce the associated costs. At least some of these objectives are met by the present invention.

BRIEF SUMMARY OF THE INVENTION The present invention relates generally to medical systems, devices, and methods, and more specifically to treating a tissue region within a patient's nasal cavity. The present invention allows for increased lateral contact or juxtaposition of a target tissue region having at least one posterior nasal nerve with the end effector surface by lateral and / or longitudinal translation of the end effector relative to the surgical probe shaft. . This improvement in lateral surface contact has several benefits, including improved patient outcome and patient safety when the end effector is in sufficient contact with the target tissue for subsequent ablation therapy.

  Embodiments include a method for treating a tissue region within a patient's nasal cavity. The method includes inserting a distal end of a surgical probe into a nostril of a patient's nasal cavity in a first configuration. The surgical probe includes an outer shaft, an inner shaft positioned within the lumen of the outer shaft and translatable relative to the outer shaft, and an end effector coupled to the distal end of the inner shaft. The distal portion of the inner shaft in the first configuration may be substantially aligned with the longitudinal axis of the outer shaft, and the end effector is a first distance from the distal end of the outer shaft in the first configuration. May be positioned. The method further includes advancing the distal end of the surgical probe from the nostril and into the central nasal passage of the nasal cavity using the surgical probe in the first configuration. The method further includes translating the inner shaft relative to the outer shaft such that the surgical probe is deployed to the second configuration. In the second configuration, the end effector is translated longitudinally to a second distance greater than the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft. . In the second configuration, the end effector may be positioned within the vicinity of the tissue region having at least one posterior nasal nerve. The method further includes ablating at least one posterior nasal nerve in the tissue region with an end effector.

  In an embodiment, the method includes first contacting the end effector with the anatomical features of the middle nasal passage to the sidewall of the nasal cavity prior to translating the inner shaft relative to the outer shaft. Translating the inner shaft relative to the outer shaft comprises translating from a rear portion of the tissue region to a front portion of the tissue region such that the end effector surface sequentially increases lateral contact with the tissue region. May be included. This ability to bring the tissue region into full contact with the end effector using the translation of the probe is advantageous because it can be achieved by stretching the nostrils or applying pressure to the septum. . In an embodiment, the first distance of the end effector from the distal end of the outer shaft may be in the range of less than 10 mm and the second distance of the end effector from the distal end of the outer shaft is 5 mm. It may be in a range of ˜20 mm. The lateral translation of the end effector away from the longitudinal axis of the outer shaft may be in the range of 10 degrees to 90 degrees.

  In an embodiment, the outer shaft may comprise an angled tip that defines an angle between the distal portion of the inner shaft and the longitudinal axis of the outer shaft in the second configuration. The probe may have an angled tip, a bias stylet, or both features that articulate the end effector away from the longitudinal axis of the outer shaft. The inner shaft may include a flexible or self-expandable material.

  The inner shaft may include a bias stylet. The step of translating the bias stylet relative to the outer shaft includes the step of: The surgical probe may be deployed to a second configuration that is not constrained by the outer shaft in a curvilinear configuration to articulate the end effector away from.

  The method may further include maintaining the outer shaft substantially stationary relative to the nostril during translation of the inner shaft relative to the outer shaft. By maintaining the outer shaft in this manner as opposed to retracting out of the nostril using the outer shaft during translation, translation of the inner shaft causes the end effector to contact the tissue region laterally. With this method, nostril extension by the outer shaft may be prevented during translation of the inner shaft relative to the outer shaft. The method may further include maintaining the outer shaft in an orientation substantially parallel to the patient's sagittal plane during translation of the inner shaft relative to the outer shaft.

  In embodiments, the end effector may include an expandable structure coupled to the distal end of the inner shaft, and the inner member encloses the inner member such that the inner member is not attached to the interior of the expandable structure. , Located at the distal end of the inner shaft extending into the expandable. The method may further include introducing a cryogenic fluid into the expandable structure such that the expandable structure expands from a contracted configuration to an expanded configuration for a tissue region. The cryogenic fluid may evaporate within the expandable structure to ablate at least one posterior nasal nerve at low temperatures. The method may further include maintaining the inner member against the interior of the expandable structure and the tissue region until at least one posterior nasal nerve is ablated at low temperature.

  In the embodiment, the inner member may include a first member and a second member. The inner member is from an expanded configuration in which the first member and the second member define a first width of the end effector between the first member and the second member, from the first member and the second member. It may be configurable up to a compressed configuration where the member defines a second width of the end effector that is smaller than the first width. The inner member is in a compressed configuration when the distal end of the surgical probe is inserted into the nostril and in an expanded configuration when the end effector is positioned within a tissue region having at least one posterior nasal nerve. Also good. The first width may be in the range of 10 mm to 20 mm.

  The first member and the second member do not overlap in the expanded configuration. The second width may be in the range of 5 mm to 19 mm. The first member and the second member may overlap in the compressed configuration. The first and second members may have a heart shape in the expanded configuration and an oblong shape in the compressed configuration. The inner member may include a planar member having an elongated loop shape.

  Embodiments further include telescopic surgical probes that can be used in the methods discussed above for treating tissue regions within the nasal cavity of a patient. The probe may include an elongated outer shaft having a distal end configured for insertion into the nostril of the patient's nasal cavity. The outer shaft has a longitudinal axis and a lumen therethrough. The probe may further include an elongated inner shaft positioned within the lumen of the outer shaft and translatable relative to the outer shaft, and an end effector coupled to the distal end of the inner shaft. The distal portion of the inner shaft may be substantially aligned with the longitudinal axis of the outer shaft, and the end effector is the first during the insertion and advancement of the surgical probe into the nasal passage of the nasal cavity. When in the first configuration, it may be positioned at a first distance from the distal end of the outer shaft. Translation of the inner shaft relative to the outer shaft causes the first distance to move away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft when the surgical probe is in the second configuration. An end effector may be configured longitudinally to a second distance greater than, wherein the end effector in the second configuration is in lateral contact with a tissue region having at least one posterior nasal nerve and at least one posterior nasal nerve. Configured to ablate. The end effector may include a cryotherapy balloon and the probe further includes a cryogenic fluid source coupled to the inner shaft and a lumen disposed within the inner shaft and in fluid communication with the cryogenic fluid source and the interior of the balloon. And may be included. Further, the end effector may be flexibly coupled to the inner shaft.

  Further embodiments may include a probe for treating a target area within the nasal cavity. The probe may include an elongate probe shaft having a distal end configured for insertion into the nasal cavity, the elongate shaft having a longitudinal axis and a lumen therethrough. The probe may further include a stylet comprising a shaft having a distal end, and an end effector disposed along the distal end of the stylet shaft. The end effector may be configured to modify the nature of the target area. The stylet shaft may have a curvature disposed proximal to the end effector. The distal end of the stylet may be retractable into the lumen of the probe shaft such that the lumen straightens the curvature of the stylet so as to position the end effector in the vicinity of the longitudinal axis. The distal end of the stylet is positioned along the curve such that the curve is positionable beyond the elongated probe shaft and the end effector is positioned laterally away from the longitudinal axis and toward the target area. It can be advanced to allow it to bend.

  In an embodiment, the target area may be located along the sidewall of the nasal cavity and may include the posterior nasal nerve in the sac. The stylet curvature is such that the end effector can be positioned relative to the target area while the probe shaft extends out of the nostril without substantially tilting the probe shaft within the nostril. May be bent. The curvature may allow the stylet to bend so that the end effector can be positioned relative to the sidewall while the probe shaft extends out of the nostril, and the application of force along the longitudinal axis of the probe shaft. Converts the force into a lateral pressure applied to the target area by the end effector. The curvature may cause the stylet to bend about 10-80 degrees from the longitudinal axis.

  In an embodiment, the temperature therapy is cryotherapy and the end effector may comprise a balloon. The end effector may be flexibly joined to the stylet shaft.

  Further embodiments may include a probe for treating a target area located within the nasal cavity. The target area may be located on the side of an axis that extends through the nostril. The probe may include a probe shaft having a distal end configured for insertion into the nasal cavity and a longitudinal axis that is alignable with an axis extending through the nostril. The probe may further include an end effector disposed along the distal end of the probe shaft so that the end effector contacts the target area while the longitudinal axis is aligned with the axis extending through the nostril. May be configured. The probe may further include a side support disposed along the distal end of the probe shaft, a portion of the side support being within the nasal cavity to hold the end effector relative to the target area. It is movable outward from the longitudinal axis laterally so as to contact the support surface. The target area may be located along the sidewall of the nasal cavity and the support surface may be located along the nasal turbinate or septum. The target area may include the posterior nasal nerve in the sac. The end effector may be disposed along the first side of the distal end of the probe shaft, the side support may be disposed along the second side of the distal end of the probe shaft, The lateral support is a collapsed configuration in which the support is placed near the longitudinal axis during insertion into the nasal cavity, and an expanded configuration in which a portion of the lateral support moves laterally outward. It is movable between. The side support is attached to the elongated probe shaft near the distal end of the probe shaft so that sliding advance of the flexible strip associated with the probe shaft transitions the side support from the collapsed configuration to the expanded configuration. It may include a flexible strip that is fixedly attached and slidably attached to the probe shaft at a proximal location. The strip may be bent outwardly from the probe shaft between the fixed mounting portion and the slidable mounting portion when in the expanded configuration. A portion of the support may contact the support surface in the nasal cavity to hold the end effector against the target area with sufficient force to apply pressure to the target area. A portion of the lateral support is laterally contacted with the support surface in the nasal cavity with sufficient force to tilt the portion of the distal end of the probe shaft away from the longitudinal axis. It may be possible to extend outward.

  In an embodiment, the lateral support may have a free end that extends outwardly from the longitudinal axis to contact the support surface and provide lateral support to the end effector. The free end may extend outwardly from the longitudinal axis by bending at a hinge, kink point, or pre-formed bend. The side support is slidably attached to the probe shaft so that sliding advancement of the strip relative to the probe shaft releases the free end and allows the free end to bend outwards laterally. May include a strip formed. The end effector may include a sheath and the side support may include an internal dilator disposed within the sheath. The dilator may have a longitudinal section aligned with the longitudinal axis and at least one expansion section, the dilator having a collapsed configuration in which at least one expansion section is disposed proximate the longitudinal section. And an expansion configuration in which at least one expansion section moves laterally outward from the longitudinal axis. The sheath may include a non-inflatable balloon configured to deliver cryotherapy. The at least one expansion section may include at least two expansion sections, and at least two of the at least two expansion sections may expand laterally outward toward the target area, while at least two Another of the expansion compartments expands outward laterally toward the surface in the nasal cavity. At least one of the at least one expansion section may move outward from the longitudinal axis laterally by a flexible warp. At least one of the at least one expansion section may move outwardly from the longitudinal axis by bending at a hinge, kink point, or flexure point. The at least one expansion compartment may be fixedly attached to the longitudinal compartment at the first location and slidably attached at the second location, with the retraction of the longitudinal compartment directed toward the second location. The first location may be pulled in, which causes at least one expansion section to expand laterally outward.

  Further embodiments may include a probe for treating a target area within the nasal cavity. The probe may include an elongated probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include an end effector disposed along the first side of the distal end of the probe shaft, and the end effector may be configured for target area temperature therapy. The probe may further include a side support disposed along the second side of the distal end of the probe shaft. The lateral support is in contact with the crushing configuration where the support is placed near the longitudinal axis during insertion into the nasal cavity and the surface near the target area to provide lateral support to the end effector. In addition, a portion of the support may be movable between an expanded configuration in which a portion of the support moves laterally outward from the longitudinal axis.

  The target area may be located along the sidewall of the nasal cavity and the surface is located along the nasal turbinate or septum. The target area may include the posterior nasal nerve in the sac. The first side and the second side of the distal end of the probe shaft may be opposite the distal end of the support probe. Thermotherapy may include cryotherapy.

  The side support is attached to the elongated probe shaft near the distal end of the probe shaft so that sliding advance of the flexible strip associated with the probe shaft transitions the side support from the collapsed configuration to the expanded configuration. It may include a flexible strip that is fixedly attached and slidably attached to the probe shaft at a proximal location. The strip may be bent outwardly from the probe shaft between the fixed mounting portion and the slidable mounting portion when in the expanded configuration. A portion of the support can extend laterally outward to contact a surface in the vicinity of the target area with sufficient force to translate pressure to the end effector relative to the target area. possible. A portion of the support is laterally outward so that it contacts the surface in the vicinity of the target area with sufficient force to tilt the portion of the distal end of the probe shaft away from the longitudinal axis. It may be possible to extend in the direction. The lateral support may have a free end that extends outwardly from the longitudinal axis to contact the surface in the vicinity of the target area and provide lateral support to the end effector. The side support may have a free end that extends outwardly from the longitudinal axis by bending at a hinge, kink point, or pre-formed bend. The side support is slidably attached to the probe shaft so that sliding advancement of the strip relative to the probe shaft releases the free end and allows the free end to bend outwards laterally. May include a strip formed.

  Further embodiments may include a probe for treating a target area within the nasal cavity. The probe may include an elongated probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include a sheath disposed along the distal end of the probe shaft. The sheath may be configured to deliver temperature therapy to the area. The probe may further include an internal dilator disposed within the sheath, the dilator having a longitudinal section aligned with the longitudinal axis and at least one expansion section, the dilator having at least one A collapsed configuration in which the expansion section is positioned in the vicinity of the longitudinal section during insertion into the nasal cavity and at least one expansion section contacts the surface in the vicinity of the target area to provide lateral support to the sheath As such, it is movable between an expanded configuration that moves laterally outward from the longitudinal axis. The sheath may comprise a non-inflatable balloon configured to deliver cryotherapy. The at least one expansion section may comprise at least two expansion sections, one of the at least two expansion sections expanding laterally outward towards the target area, while at least two expansion sections The other of these expands laterally outward toward the intranasal surface opposite the target area.

  The target area may comprise a portion of the side wall containing the proximal nasal nerve, and the surface in the nasal cavity facing the target area comprises the turbinate or septum. At least one of the at least one expansion section may move outward from the longitudinal axis laterally by a flexible warp. At least one of the at least one expansion section may move outwardly from the longitudinal axis by bending at a hinge, kink point, or flexure point. The at least one expansion compartment may be fixedly attached to the longitudinal compartment at the first location and slidably attached at the second location, with the retraction of the longitudinal compartment directed toward the second location. The first location may be pulled in, which causes at least one expansion section to expand laterally outward.

  Further embodiments may include a probe for treating a target area within the nasal cavity. The probe may include an elongated probe shaft having a longitudinal axis and a distal end configured for insertion into the nasal cavity. The probe may further include an end effector disposed along the distal end of the probe shaft. The end effector may be configured to deliver treatment to the target area. The probe may further include an extension rod having a proximal end that is alignable with the longitudinal axis of the extension probe and a curved distal end that extends outwardly laterally from the longitudinal axis. The distal end may have a tip that is positionable relative to a support surface within the nasal cavity, and positioning the tip relative to the support surface presses the end effector against the target area during treatment delivery. To do. The curved distal end may have a curvature of about 90 degrees so that the distal end of the rod is substantially perpendicular to the longitudinal axis. The rod can be malleable to adjust the curvature of the curved distal end. The end effector may have a wide surface configured to contact the target area, and the distal end of the rod is rotatable between a position parallel to the wide surface and a position perpendicular to the wide surface. possible.

  The target area may be located along the sidewall of the nasal cavity and the support surface may be located along the nasal turbinate or septum. The target area may include the posterior nasal nerve in the sac.

  The rod may be advanceable and retractable relative to the probe shaft. The rod may be advanceable such that the curved distal end is positionable distal to the end effector, such that the end of the support surface adjacent to the target area is positionable relative to the distal tip. Extends around the effector. The end effector may comprise an inflatable balloon and the rod may stabilize the balloon during delivery of temperature therapy. Thermotherapy may include cryotherapy.

These and other embodiments are described in further detail in the following description, taken in conjunction with the accompanying drawings.
Citation by reference

All publications, patents, and patent applications described herein are specifically and individually indicated as if each individual publication, patent, or patent application was incorporated by reference. To the same extent, they are incorporated herein by reference.

  The novel features of the invention are set forth with particularity in the appended claims. A further understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

FIG. 1 provides an illustration of the anatomy of the nose. FIG. 2 provides an illustration of the internal view of the nasal anatomy. FIG. 3 illustrates a portion of the nasal cavity including the target treatment area. FIG. 4A illustrates a probe having a shaft and a treatment end effector inserted into the nostril of the nose. FIG. 4B illustrates the probe of FIG. 4A tilted in the nostril. 5A-5B illustrate an embodiment of a probe that allows a treatment end effector to be moved laterally while the shaft maintains position. 6A-6B illustrate the device of FIGS. 5A-5B in use in the nasal cavity. 6A-6B illustrate the device of FIGS. 5A-5B in use in the nasal cavity. 7A-7B illustrate an embodiment of a probe that provides lateral support to the treatment end effector. 7A-7B illustrate an embodiment of a probe that provides lateral support to the treatment end effector. FIG. 7C illustrates the probe where the side support is advanced to tilt the distal end of the probe shaft. FIG. 8 illustrates the probe of FIGS. 7A-7C inserted into the nostril of the nose. FIG. 9 illustrates an embodiment of a probe having a free end that provides lateral support to the treatment end effector. 10A-10B illustrate an embodiment of a probe having an internal dilator. 11A-11B illustrate another embodiment of a probe having an internal dilator. 12A-12B illustrate an example of the end effector embodiment of FIGS. 10A-10B in use. 12A-12B illustrate an example of the end effector embodiment of FIGS. 10A-10B in use. 13, 14A-14B, 15, 16 illustrate another embodiment of a probe that provides lateral support to the treatment end effector. 13, 14A-14B, 15, 16 illustrate another embodiment of a probe that provides lateral support to the treatment end effector. 13, 14A-14B, 15, 16 illustrate another embodiment of a probe that provides lateral support to the treatment end effector. 13, 14A-14B, 15, 16 illustrate another embodiment of a probe that provides lateral support to the treatment end effector. 17A-17D illustrate an embodiment of a probe in which the lateral support is advanceable so that its distal end can be positioned distally beyond the end effector. 18A-18B illustrate an example of the embodiment of FIGS. 17A-17D in use. 18A-18B illustrate an example of the embodiment of FIGS. 17A-17D in use. FIG. 19A illustrates an embodiment of a system that guides and maintains a treatment end effector laterally to assist in reaching a target area along the nasal passage. FIG. 19B illustrates a similar catheter in use without a curved guidewire. 20A-20D illustrate an embodiment of an end effector member.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates generally to medical devices, systems, and methods, and more particularly to devices, systems, and methods for treating rhinitis. Such treatment of rhinitis is accomplished by reducing or interrupting neural signals transmitted from the sphenoid palate ganglion to the nasal mucosa via the posterior nasal nerve. Reduction or interruption of neural signals is achieved by various methods, in particular by application of physical therapy (compression or amputation), hyperthermia (high or low temperature), or chemotherapy (alcohol or anesthetic injection). be able to. Examples of hyperthermia include cryotherapy, cold neuromodulation, cold modulation, freeze-thaw, cryoablation, and thermal ablation. Specific target areas within the nasal cavity have been found to be particularly effective in treating rhinitis. This target area is located along the side wall W in the middle nasal passage in the sac CDS. The sac CDS in the middle nasal passage is defined “upward” by the ethmoid follicle, defined rearward by the last attachment point of the middle turbinate T2 to the sidewall, and by the lower turbinate T3 attachment to the sidewall. Defined below, anteriorly defined by the posterior tail of the ridges, and defined inwardly by the outside of the middle turbinate. Target area of the bag path may area from about 177 mm ^2, in ^embodiments, may range 13mm ² ~315mm 2. The target area may include a concave surface portion and a portion projecting out of the wall on the lower side where the lower turbinate adheres. FIG. 3 illustrates a portion of the nasal cavity including the target area 10. In this illustration, a portion of the left side of the patient's face has been omitted to allow the inside of the nasal cavity to be visible, and specifically, the septum and the left side of the nose N have been omitted. Yes. Thus, the upper, middle and lower turbinates T1, T2, T3 on the right side of the face are visible along the sidewall W. An arrow 12 indicates a straight path through the nostril NO toward the location of the target area 10.

  4A shows the shaft 22 and the middle nasal passage, inserted into the right nostril N, in the direction substantially corresponding to the arrow 12 in FIG. 3 and below the middle turbinate and above the lower turbinate. 1 illustrates an embodiment of a probe 20 having a treatment end effector 24 advanced into the device. A part of the nasal cavity shown in FIG. 4A is a cross-sectional view from above. As shown, a portion of the side wall W in the target area 10 is concave. The posterior lateral nasal nerve N2 passes through the side wall of the butterfly ostium located in or slightly above the middle turbinate attachment to the side wall W. The portion of the posterior nasal nerve N2 extends in the nasal cavity and distributes the nerves to the mucosa along the side wall W of the sac CDS that defines the target area 10. By applying one or more of the above treatments across the target area 10 using the end effector 24 of the probe 20, the parasympathetic signal passing therethrough is reduced or interrupted; Reduce nasal inflammation. The location and contour of the target area 10 in the culmination CDS may prevent contact of the treatment end effector 24 across the entire target area 10. Without contact across the entire target area, the treatment may be less effective or ineffective. Thus, it is desirable to use the end effector 24 to have full contact with the target area in the cuff CDS and apply pressure to the target area 10. Application of such pressure compresses and thins the tissue layer (nasal mucosa) between the nerve area N2 and the end effector 24, bringing the end effector 24 closer to the nerve, and for cryoablation applications, the temperature of the nerve is in degrees Celsius − Allows to reach 20 degrees. Such pressure can also reduce blood flow through the target area 10. Both of these aspects can increase the penetration and area of treatment and increase the effectiveness of hyperthermia.

  In an embodiment, as shown in FIG. 4B, the end effector 24 enters the bladder CDS and contacts the sidewall W to contact and apply pressure to the target area 10. The probe 20 may be angled laterally with respect to the sagittal plane so as to reach the lower turbinate T3 and below the middle turbinate T2. As shown, the angle relative to the sagittal plane SP used to reach the target 10 using the end effector 24 causes the shaft 22 of the probe 20 to press the septum S and stretch the nostril NO. You may let them. This pressure on the septum and nostril stretch can be uncomfortable and harmful to the patient. Further, the occlusion caused by the septum S, the lower turbinate T3, and the nasal NO limits the amount of pressure that can be applied to the contact area of the end effector 24 and the target area 10, thereby limiting the effectiveness of the treatment. Can do. In an embodiment, the shaft 22 may include a bent portion such that the end effector 24 is offset from the longitudinal axis of the shaft 22. The bent portion may allow a more complete coverage of the target area 10 by the end effector 24. In an embodiment, the flexure causes the width of the probe 20 to be greater than a linear probe and thus through the nasal passage through the nasal cavity without causing patient discomfort from pushing into the nasal turbinates and / or septum. In order to advance the bending probe into the shaft, the shaft may be made from a flexible material. The flexible material may be elastic and be able to straighten when advanced into the nasal cavity without causing excessive pressure on the nostrils and septum. When the end effector reaches the middle nasal passage, the shaft will bias due to the elasticity of the material and return to the bent configuration. Returning to the flexed configuration translates the end effector laterally toward the target area, contacts and applies pressure to the target area.

  5A-5B show an embodiment of probe 30 comprising an outer shaft 32 and an inner shaft 38, also referred to as a stylet. Inner shaft 38 is located within lumen 36 of outer shaft 32. Inner shaft 38 includes a distal end portion 42. An end effector 34 is attached to the distal end portion. The inner shaft 38 can translate relative to the outer shaft 32. The translation may be actuated using a trigger or similar mechanism located on the handle to which the probe 30 is attached. The inner shaft 38 is translated such that the end effector 34 is away from the distal end of the outer shaft 32 from the first configuration shown in FIG. 5A where the end effector 34 is proximate to the distal end of the outer shaft 32. Translations may be made up to the second configuration shown in FIG. 5B. In the first configuration, the end effector 34 is positioned to be substantially aligned with the longitudinal axis 40 of the outer shaft 32. For example, the end effector may not extend more than 15 mm from the longitudinal axis in the first configuration. This allows easy insertion into the nostril NO and advancement into the nasal passage such as the middle nasal passage. As shown in FIG. 5B, in the second configuration, the end effector 34 is separated from the distal end of the outer shaft 32 both longitudinally and laterally by the longitudinal axis of the outer shaft 32. Translated at an angle to 40.

  The outer shaft 32 is sized and configured to be advanceable in the nasal cavity through the patient's nostril NO by a user outside the patient. In an embodiment, the outer shaft 32 is 80 mm or longer and 4 mm or less in diameter and is made from a malleable or rigid material such as stainless steel or heat treated stainless steel. In an embodiment, the outer shaft 32 has a substantially linear configuration that is semi- malleable to rigid and extends along a linear longitudinal axis 40. The straightness of the outer shaft 32 allows the outer shaft 32 to be comfortably present in the nostril NO.

End effector 34 is affixed to the distal end of shaft 42. In an embodiment, the end effector 34 comprises a flexible inner member and a thin film outer member. The inner member can be made from stainless steel, nitinol, or higher durometer plastic. The thin film outer member can be made from a polymer film with a thickness <0.005 inches. The film material can be nylon, LDPE, urethane, PET, or a coextrusion of these types. For cryoablation applications, the end effector may be achieved to reach the freezing temperature on all surfaces of the thin film outer member. Sidewall-facing surface of the end effector, with a preferred circular area of 177 mm ^2, has an area ranging 13~315mm ^2. The end effector may be inflatable, and the width between the side wall facing surface in the contracted state when advancing to the target area and the mid turbinate facing surface of the end effector 34 may be 0.2-1 mm. Good. Once over the target area 10, the end effector may be transitioned to an expanded state with a width of 1 mm to 10 mm. In an embodiment, the sidewall facing surface is circular with a diameter of 15 mm. In embodiments, the end effector 34 is attached to the distal end portion 42 either along the longitudinal axis 44 of the distal end portion 42 or at an angle relative to the longitudinal axis 44 of the distal end portion 42.

  In embodiments, the inner shaft 38, including the distal end portion 42, is constructed from a flexible material such as nitinol, spring steel, Elgiloy, or a flexible polymer. Inner shaft 38 may include a bend that biases the distal end portion into a configuration in which the distal end portion is at an angle relative to other portions of the inner shaft. The flexible material is the distal end portion 42 when the probe 30 is in the first configuration and the distal end portion 42 is positioned within the lumen 36 of the outer shaft 32 as shown in FIG. 5A. And configured to allow the bend to straighten with respect to other portions of the inner shaft 38. In embodiments, the inner shaft 38 may be made from a plurality of components and / or materials. The distal end portion 42 may be made from a flexible material and the other portion of the inner shaft 38 may be made from a semi-rigid to rigid material that is affixed to the distal end portion 42.

  In an embodiment, the distal end of the outer shaft includes an angled tip 46. Inner shaft 38 is advanced through lumen 36 and distal end portion 42 extends out of outer shaft 32 through angled tip 46. Angled tip 46 includes a lumen that directs inner shaft 38 out of angled tip 46 at a desired angle relative to longitudinal axis 40 of outer shaft 32, as illustrated in FIG. 5B. In the embodiment, the angle θ ranges from 10 to 90 degrees, more specifically from 20 to 70 degrees. The end effector 34 translates between a first configuration at a distance d1 from the distal end of the outer shaft and a second configuration at a distance d2 from the distal end of the outer shaft. The difference in distance is 3 mm. It may range from ˜50 mm, more specifically from 5 mm to 20 mm. During the procedure, the range of translation may be based on the patient anatomy and the inner shaft may be able to translate to any position within the range.

  The probe 30 may be used in a treatment method where the target area can be treated without stretching the nostrils or pushing the septum. 6A-6B illustrate the device of FIGS. 5A-5B in use in the nasal cavity. During the procedure, the probe 30 is placed in a first configuration with an end effector 34 proximate to the distal end of the outer shaft 32, the distal end, ie, the end effector end, being inserted into the patient's nostril. Is done. During this step, the end effector 34 may be in a contracted configuration. FIG. 6A illustrates the probe 30 after it has been partially advanced into the nasal cavity. While being advanced, the probe 30 remains in the first configuration as the end effector 34 advances from the nostril into the middle nasal passage. During this insertion, the longitudinal axis of the outer shaft 32 remains in a plane substantially parallel to the sagittal plane SP, causing pressure on the septum and not angled to extend the nostril. Probe 30 continues to be advanced and is further inserted between and past the septum and medial turbinate T3. The end effector 34 inserts the upper edge of the end effector 34 to the side of the middle turbinate, and keeps the end effector 34 below the middle turbinate T2 while moving the probe 30 rearward and slightly upward along the lower turbinate. Is advanced into the middle nasal passage. The probe 30 is advanced until the distal end of the end effector 34 touches the attachment of the turbinate T2 to the side wall in the tract CDS. As shown in FIG. 6B, when the distal end of the outer shaft 32 is inserted under the middle turbinate and the distal tip of the end effector touches the attachment point of the middle turbinate to the side wall, the inner shaft 38 is The distal end portion 42 then translates the end effector 34 laterally and rearward away from the outer shaft 32 at a defined angle θ defined by the angled tip 46 toward the target area 10. Is advanced in the outer shaft 32. The inner shaft 38 may be advanced until the distal end of the end effector 34 slides up relative to the target area 10 along the attachment and along the sidewall W. When the distal end of the end effector 34 contacts the rear surface of the target area 10, the probe 30 may be further translated backward, or the end effector 34 may further be a portion of the end effector 34 and / or a distal end portion 42. May be translated from the outer shaft 32 to bend or rotate to increase the surface area of the end effector 34 that contacts the target area 10 in the forward direction. Thus, using the probe 30 substantially angles the probe shaft 32 and allows the end effector 34 to be positioned relative to the target area without causing pressure on the septum or nostril stretch. . Thus, translation of the force is more effective and comfortable for the patient than angling the probe shaft as shown in FIG. 4B. However, in certain instances, it can be appreciated that the probe shaft 32 may additionally be angled to accommodate specific anatomical features. In such cases, such tilting is significantly less without the ability to extend the end effector 34 laterally.

  Once the end effector 34 is desirably installed relative to the target area 10, treatment may be applied. Such treatment may include heat, such as thermal ablation, or low temperature, such as cryotherapy (freeze ablation). Cryogenic liquid was filed on September 30, 2014, co-owned and entitled “APPARATUS AND METHODS FOR TREATING RHIINITIS”, which is incorporated herein by reference in its entirety for all purposes. Delivered through a small delivery tube as described in US patent application Ser. No. 14 / 503,060.

  7A-7B illustrate an embodiment of the probe 50 that provides lateral support to the treatment end effector 54. In an embodiment, the probe 50 allows the end effector 54 to be moved laterally while a portion of the probe shaft 52 maintains its position. The probe 50 includes an elongate shaft 52 that is sized and configured to be advanceable along a nasal passage, such as the middle nasal passage between the lower and middle turbinates, through the patient's nostril NO. The shaft 52 has a distal end 55 and a proximal end 57, and the end effector 54 is disposed at or along the distal end 55. In this embodiment, the end effector 54 comprises an inflatable sheath or balloon 56 mounted on the elongate shaft 52. In an embodiment, the balloon 56 can be filled with an evaporating liquid cryogen and thus through the Joule-Thompson effect so that a cryogenic ablation or cryogenic modulation therein delivers a low temperature to the target area. Configured for cryotherapy, producing very low temperatures. In this embodiment, the probe 50 further includes a side support 58 that is disposed along the shaft 52 in a manner that provides lateral support to the end effector 54 when in use. In this embodiment, the lateral support 58 extends along the side of the probe shaft 52 and is attached to the distal end 55 and then extends without being attached toward the proximal end 57. Provide a rod, strip, or ribbon. A portion of the unsupported support 58 extends through a lumen in the shaft 52 such that it is held parallel to the longitudinal axis 40 of the shaft 52 and flush with the shaft 52. The remaining portion of the unsupported support 58 remains free to move laterally away from the shaft 52 perpendicular to the longitudinal axis 40 to provide lateral support.

  FIG. 7A illustrates the probe 50 in a collapsed configuration where the balloon 56 is not inflated and the side support 58 is flush with the shaft 52 from the distal end 55 to the proximal end 57. The shaft 52 can be easily inserted into the nostril NO in the collapsed configuration. FIG. 7A shows that the balloon 56 faces a target area (not shown) and a side support 58 on the opposite side of the probe 50, and the side support 58 is used to support the balloon 56. Shown is a shaft 52 oriented to face the tissue surface T opposite the target area so that it can. Within the nose, the target area may be present, for example, along the side wall of the sac C, and the opposite tissue surface would be the septum or other nearby tissue surface. FIG. 7B shows that the balloon 56 is inflated for treatment and a portion of the unattached portion bends outwardly from the longitudinal axis of the shaft 52 within the area of the end effector 54 as shown. The probe 50 is illustrated in an expanded configuration in which the side supports 58 are extended so as to bend or flex. Such expansion of the side support 58 is accomplished by advancement of the side support 58 toward the distal end 55 through a lumen in the shaft 52. The side support 58 remains flush with the shaft 52 in the lumen during advancement, but the side support 58 moves sideways from the shaft 52 in response to exiting the lumen from which the support 58 can move freely. Turn outwards toward In embodiments, the side support 58 is composed of a flexible material such as nitinol, nylon, spring steel, polyethylene, Teflon, or polyurethane. The lateral support 58, as shown, is such that the distance between the additional warpage of the lateral support and the surface of the balloon causes the lateral support to contact the nearby tissue T and the balloon to contact the target area. Advances to the point to turn. In some cases, the balloon 56 is inflated sufficiently to contact the target area while the shaft 52 remains aligned with the longitudinal axis 40. In such cases, the side support 58 is bent relative to the tissue T opposite the target area to hold the balloon 56 in place and apply a lateral force to the balloon 56 and the target area. Also good. This applies pressure to the target area, thins the tissue in the target area, and can bring the balloon closer to the underlying target nerve. Such pressure can also reduce blood flow through the area. Both of these aspects can increase the penetration of treatments such as creating deeper freezing zones.

  In some cases, the inflated balloon 56 cannot contact the target area while the shaft 52 remains aligned with the longitudinal axis 40. In such cases, the side support 58 may be further advanced through the lumen to allow additional warping to the tissue T, as illustrated in FIG. 7C. As more portions of the side support 58 are extended, an increasing force is applied to the distal attachment point of the side support 58 to the shaft 52 (where the side support 58 is Attached at the distal tip 59 of the shaft 52). Such increasing force causes the distal end 55 of the shaft 52 to tilt away from the longitudinal axis 40, such as by an angle θ. In the embodiment, the angle θ ranges from 10 degrees to 90 degrees, more specifically from 30 degrees to 60 degrees. This allows the balloon 56 to reach a more laterally located target area, such as in a sac, while maintaining alignment of the proximal end 57 of the shaft 52 with the longitudinal axis 40.

  FIG. 8 illustrates the probe 50 of FIGS. 7A-7C inserted into the nostril NO of the nose N. FIG. Probe 50 may be advanced therein with the collapsed configuration of FIG. 7A. Once the balloon 56 is positioned so that it is desirably aligned with the target area 10 along the wall W of the sac CDS, the balloon 56 is inflated and the side support 58 is a free moving portion of the side support 58. Is advanced to allow lateral extension of the. The side support 58 may extend laterally until it contacts the underside of the middle turbinate T2 and / or the septum S and provides resistance and side support to the inflated balloon 56. In some cases, the support 58 is further extended to push the balloon 56 against the target area 10. This assists in applying pressure to the target area 10 and potentially shortens the distance between the balloon 56 and the underlying target nerve N2. The support 58 also helps maintain such contact and pressure against the target area 10 during a procedure procedure such as cryotherapy. The support provides consistent and thorough contact, shortens the distance between the applied treatment and the target nerve N2, reduces blood flow, and reduces patient discomfort associated with probe movement and tilting. By reducing, treatment outcome may be improved.

  In embodiments, the side support 58 may be attached to the shaft 52 at any suitable location, such as any distance from the distal tip 59. Variations in the location of the attachment points can create lateral support at different locations along the shaft 52. Such variations can provide different places for pressure application by the balloon 56. Such variations can also provide different tilt angles of the distal end of shaft 52. In embodiments, the support 58 may be retained on the shaft 52 by features other than passing through a lumen in the shaft 58. For example, the support 58 may be mounted on the exterior of the probe shaft 52 that passes under various straps or in the vicinity of the shaft 52 or through various eyelets that hold the support 58 relative thereto. Good. Similarly, support 58 may be slidably attached to shaft 52 at one or more points in addition to the attachment points. Such a slidable attachment point may be achieved by passing the support 58 through a short lumen in the shaft 52 or under a strap or through a small hole outside the shaft 52. Thus, as the support 58 is advanced, the support 58 can bend or bend outward laterally around the attachment point to create more than one side support.

  FIG. 9 provides lateral support to the treatment end effector 64, which in some cases allows the end effector 64 to be moved laterally while a portion of the probe shaft 62 maintains its position. Figure 6 illustrates an embodiment of a probe 60. In this embodiment, the probe 60 is sized and configured to be advanceable along a nasal passage, such as the middle nasal passage between the lower and middle turbinates, through the patient's nostril NO. Is provided. The shaft 62 has a distal end 65 and a proximal end 67, and the end effector 64 is disposed at or along the distal end 65. In this embodiment, the end effector 64 includes an inflatable sheath or balloon 66 mounted on the elongate shaft 62. In an embodiment, the balloon 66 is configured for cryotherapy, where the balloon 66 can be filled with a cryogenic liquid such that cryogenic ablation or cryomodulation into it delivers a low temperature to the target area. In this embodiment, probe 60 further includes a side support 68 that is disposed along shaft 62 in a manner that provides lateral support to end effector 64 when in use. In this embodiment, the lateral support 68 comprises an elongated rod, strip, or ribbon that extends within the lumen along the side of the probe shaft 62 parallel to the longitudinal axis 40. Side support 68 is not attached to shaft 62 or balloon 66. The support 68 can be advanced through the lumen and outwardly outward such that the distal tip 67 of the support 68 separates from the shaft 62 and the balloon 66 as the bend 61 is advanced out of the lumen. Having a hinge, kink point, or pre-formed bend 61 near the distal end of the side support, which is configured to be moved to the side. In an embodiment, the side support 68 is made of nitinol or a shape memory material, and the side support 68 is perpendicular to the longitudinal axis 40 to return to its pre-formed shape and provide support laterally. The distal tip 67 may be moved outward. In an embodiment, the distal end of the support 68 forms an angle θ with the longitudinal axis. In some embodiments, the angle θ ranges from 10 degrees to 90 degrees, more specifically from 30 degrees to 60 degrees.

  In an embodiment, the inflated balloon 66 cannot contact the target area while the shaft 62 is aligned with the longitudinal axis 40. In an embodiment, a side support 68 may be used that has a bend 61 located a further distance from the distal tip 67. This causes more portions of the support 68 to extend laterally outward. Similarly, the support 68 may be positioned such that the bend 61 is located near the distal tip 69 of the shaft 62. Thus, as more portions of the support 68 are extended, the force applied to the distal tip 69 of the shaft 62 is increased. Such increasing force causes the distal end 65 of the shaft 62 to tilt away from the longitudinal axis 40. This allows the balloon 66 to reach a more laterally located target area, such as in a sac, while maintaining alignment of the proximal end 67 of the shaft 62 with the longitudinal axis 40.

  Referring back to FIG. 9, in an embodiment, the probe 60 can be advanced into the nostril NO of the nose N in a collapsed configuration where the support 68 is against the shaft 62 and the balloon 66 is not inflated. Once the balloon 66 is positioned so that it is desirably aligned with the target area 10 along the wall W of the boulevard CDS, the balloon 66 is inflated and the support 68 is bent toward the free end of the support 68. It is advanced until it is possible to extend it. The free end of the support 68 is lateral until its distal tip 67 contacts the underside of the mid-nasal turbinate T2 and / or septum S, providing resistance and lateral support to the inflated balloon 66. Extending towards. In some cases, the support 68 is further extended to push the balloon 66 against the target area 10. This assists in applying pressure to the target area 10 and potentially shortens the distance between the balloon 66 and the underlying target nerve N2. The support 68 also helps maintain such contact and pressure against the target area 10 during a procedure procedure such as cryotherapy. The support provides consistent and thorough contact, shortens the distance between the applied treatment and the target nerve N2, reduces blood flow, and reduces patient discomfort associated with probe movement and tilting. By reducing, treatment outcome may be improved.

  In embodiments, the bend 61 may be placed at any suitable location, such as any distance from the distal tip 67. Similarly, the support 68 may be advanced or retracted to position the bend 61 anywhere along the probe shaft 62. Variations in the location of the attachment points can create side support at different locations along the shaft 62. Such variations can provide different places for pressure application by the balloon 66. Such variations can also provide different tilt angles of the distal end of shaft 62. In embodiments, the support 68 may be retained on the shaft 62 by features other than passing through a lumen in the shaft 62. For example, the support 68 may be mounted on the exterior of the probe shaft 62 that passes under various straps or in the vicinity of the shaft 62 or through various eyelets that hold the support 68 relative thereto. Good.

  10A-10B, 11A-11B have an end effector 74 that extends laterally to reach a target area along the sac while a portion of the probe shaft 72 maintains its position. 1 illustrates an embodiment of a probe 70. In this embodiment, the probe 70 is sized and configured to be advanceable along a nasal passage, such as the middle nasal passage between the lower and middle turbinates, through the patient's nostril NO. Is provided. Shaft 72 has a distal end 75 and a proximal end (not shown), and end effector 74 is disposed at or along its distal end 75. End effector 74 comprises an inflatable or non-inflatable sheath or balloon 76 having an internal dilator 78. Balloon 76 may be configured for cryotherapy, which can be filled with a cryogenic liquid such that balloon 76 delivers a low temperature to the target area for cryoablation or cryomodulation therein. Inner dilator 78 acts as a scaffold and is constructed of a suitable material to provide such a structure, such as a metal or polymer wire, filament, nitinol, or the like. The material is flexible so that it is atraumatic, but rigid so as to provide support to the balloon 76, especially when used without being inflated. The dilator 78 includes a longitudinal section 79 that is aligned with the longitudinal axis 40 of the elongated probe shaft 72. The longitudinal section 79 is sequential to act as a pull wire 82 that is connected to the pull wire 82 or typically extends through the probe shaft 72 to its proximal end. The dilator 78 also includes at least one expansion compartment 80. FIG. 10A illustrates an embodiment having two extended sections 80, one on each side of the longitudinal section 79. The expansion section 80 is fixedly attached to the longitudinal section 79 at a first location 84 such as at or near its distal tip and is slidable at a second location 86 proximal to the first location 84. It is attached. In this embodiment, each expansion section 80 has a hinge, kink point, or flex point 88. Retraction of the pull wire 82 causes the longitudinal section 79 to retract. As the first location 84 is pulled toward the probe shaft 72, the second location 86 is retracted into the probe shaft 72, thus, as illustrated in FIG. Movement to the side toward 88 is restricted. Therefore, the bending point 88 moves in a direction perpendicular to the longitudinal axis 40. The dilator 78 is now in the expanded position and structurally supports the balloon 76. In embodiments, the flex point 88 may be located at various positions to vary the shape of the dilator 78 in the expanded position. Similarly, each expansion section 80 may include more than one flex point 88.

  11A-11B illustrate a similar embodiment of the dilator 78. FIG. 11A illustrates an embodiment having four extended sections 80, two on each side of the longitudinal section 79. The expansion section 80 is fixedly attached to the longitudinal section 79 at a first location 84 such as at or near its distal tip and is slidable at a second location 86 proximal to the first location 84. It is attached. Here, each expansion section 80 is sufficiently flexible to bend without a bending point. Retraction of the pull wire 82 causes the longitudinal section 79 to retract. As the first location 84 is drawn toward the probe shaft 72, the second location 86 is retracted into the probe shaft 72, thus, as shown in FIG. It is limited to bend in the direction. Accordingly, the expansion section 80 moves in a direction perpendicular to the longitudinal axis 40. The dilator 78 is now in the expanded position and structurally supports the balloon 76.

  12A-12B illustrate the end effector 74 embodiment of FIGS. 10A-10B in use. FIG. 12A illustrates that the probe 70 is inserted into the nostril NO of the nose N in a collapsed configuration in which the expansion section 80 is substantially aligned with the longitudinal axis 40. Once the balloon 76 is positioned so that it is desirably aligned with the target area 10 along the wall W of the canal CDS, 78 is expanded as illustrated in FIG. 12B. Here, the puller wire 82 is retracted, causing the longitudinal section 79 to retract. As the first location 84 is pulled toward the probe shaft 72, the second location 86 is retracted into the probe shaft 72, thus moving each expansion section 80 laterally toward its flex point 88. Be restricted. The probe 70 is positioned such that at least one flex point 88 contacts the nose wall W while the probe shaft 72 maintains its position in the nostril NO. FIG. 12B illustrates at least one flex point 88 that contacts the target area 10 to apply pressure thereto and improve treatment to the underlying nerve N2. FIG. 12B also illustrates at least one flex point 88 that contacts the septum S and provides reinforcement or side support to the end effector 74. This may also be used to increase the pressure applied to the target area. In embodiments, the dilator may have only one dilation section 80 if desired, such as to contact the nasal sidewall W. In such cases, it may be sufficient rear support to hold the probe firmly. In embodiments, the dilator 78 may be used in combination with a mechanism for cryogen delivery to the balloon 76, or the dilator 78 itself may serve as a cryogenic line.

  13, 14A-14B, 15, 16 illustrate an embodiment of the probe 100 that provides lateral support to the treatment end effector 104. FIG. In this embodiment, the probe 100 is sized and configured to be advanceable along a nasal passage, such as the middle nasal passage between the lower and middle turbinates, through the patient's nostril NO. Is provided. The shaft 102 has a distal end 105 and a proximal end (not shown), and the end effector 104 is disposed at or along the distal end 105. In this embodiment, the end effector 104 includes a non-inflatable sheath or balloon 106 mounted on the elongate shaft 102. In an embodiment, the end effector 104 is configured for cryotherapy and includes a cryogenic line 103 for cryogen delivery so as to deliver a cryogenic temperature to the target area for cryoablation or cryomodulation thereto. In this embodiment, the probe 100 further includes a side support 108 that is positioned along the shaft 102 in a manner that provides support to the balloon 106 laterally when in use. In this embodiment, the side support 108 comprises an elongated rod 110 that extends along the side of the probe shaft 62 parallel to the longitudinal axis 40, such as within a lumen or attachment feature. The elongate rod 110 has a curved distal end 112. In this embodiment, the distal end 112 has a curvature of about 90 degrees so that the distal end 112 is substantially perpendicular to the longitudinal axis 40. However, other curvatures such as 45-135 degrees may be used. In embodiments, the elongate rod 110 is malleable so that the curvature can be adjusted as needed.

  In this embodiment, the extension rod 110 is rotatable, advanceable, and retractable. 14A-14B illustrate end views of the end effector 104 of FIG. 13 while the extension rod 110 is in various positions. FIG. 14A illustrates the extension rod 110 positioned such that the distal end 112 is parallel to the large surface of the balloon 106. The extension rod 110 is typically in this position during insertion into the nostril NO so as to minimize dimensions. Once the balloon 106 is desirably placed near the target area, the extension rod 110 is rotated as illustrated in FIG. 14B so that the distal end 112 is substantially perpendicular to the wide surface of the balloon 106. The This allows the extension rod 110 to apply a force to the balloon 106, as will be illustrated below. FIG. 15 provides a side view of the end effector 104 of FIG. 14B. As shown, the distal end 112 of the extension rod 110 extends outwardly laterally away from the longitudinal axis 40.

  FIG. 16 illustrates the probe 100 of FIG. 13 in use treating a target area 10 along the nasal passageway CDS. In an embodiment, the probe 100 is inserted into the nostril NO of the nose N in a collapsed configuration in which the extension rod 110 is rotated such that its distal end 112 is positioned along the large surface of the balloon 106. The Once the balloon 106 is positioned so that it is desirably aligned with the target area 10 along the wall W of the sac CDS, the rod 110 is moved so that the distal end 112 moves laterally away from the balloon 106. , Rotated. The distal end 112 is positioned relative to the middle turbinate T2 and / or the septum S to provide reinforcement or side support to the balloon 106. In some embodiments, this stabilizes the balloon 106, and in other embodiments it also applies pressure to the target area 10 and improves treatment to the underlying nerve N2. In embodiments, the distal end 112 may be positioned with respect to any suitable tissue so as to provide the desired support. Similarly, the elongate rod 110 may be rotated by any amount so that the distal end 112 is perpendicular to the wide surface of the balloon 106 or is positioned at any angle relative to the balloon. Further, the rod 110 may be advanced or retracted relative to the probe shaft 102 to position the distal end 112 at various locations along the balloon 106. In an embodiment, the probe shaft 102 may tilt slightly within the nostril NO, allowing the end effector 104 to fully contact the target area 10. However, such tilting is greatly diminished compared to such a procedure without the side support 108.

  In some embodiments, the elongate rod 110 is advanceable such that the distal end 112 can be positioned distally beyond the balloon 104, as illustrated in FIGS. 17A-17D. Again, the extension rod 110 is rotatable so that the distal end 112 can be positioned parallel to the wide surface of the balloon 106, as illustrated in FIG. 17A. The extension rod 110 is typically in this position during insertion into the nostril NO so as to minimize dimensions. Once the balloon 106 is desirably placed in the vicinity of the target area, the elongate rod 110 extends across the balloon 106 with the distal end 112 substantially perpendicular to the wide surface of the balloon 106 (facing out of the page). Rotate as shown in FIG. 17B. This allows the extension rod 110 to apply posterior support to the balloon 106, as will be illustrated hereinafter. FIG. 17C provides a side view of the end effector 104 of FIG. 17B. As shown, the distal end 112 of the extension rod 110 extends laterally outwardly across the balloon 106 away from the longitudinal axis 40. In this embodiment, the balloon 106 is inflatable. FIG. 17D illustrates the balloon 106 in an inflated state. As shown, the balloon 106 favors expansion away from the rod 110, which provides posterior support and stability for the balloon 106.

  18A-18B illustrate an example of the embodiment of FIGS. 17A-17D in use treating a target area 10 along the nasal passageway CDS. In an embodiment, the probe 100 is in a collapsed configuration in which the elongate rod 110 is rotated so that its distal end 112 is positioned along a large surface of the balloon 106, as illustrated in FIG. Inserted into N nostril NO. Here, the curvature of the rod 110 is not visible because the distal end 112 extends into the page. Once the balloon 106 is positioned so that it is desirably aligned with the target area 10 along the wall W of the sac CDS, the rod 110 is moved laterally toward the balloon 106 so that the distal end 112 of the balloon 106 Rotated to extend over the most distal end. The distal end 112 is positioned relative to the nasal sidewall W near the target area 10 as illustrated in FIG. 18B. In embodiments, the distal end 112 can be malleable to adjust the curvature to accommodate various anatomy. Balloon 106 is inflated prior to, after, or during positioning of distal end 112 relative to sidewall W. The rod 110 directs the balloon 106 towards the wall W and provides rear support to stabilize the position of the balloon 106 and increase contact with the wall W. In some embodiments, the rod 110 also assists in applying pressure to the target area 10 and improves treatment to the underlying nerve N2. Typically, the rod 110 and probe shaft 12 maintain a position with the nostril NO during the procedure, however, the probe shaft 102 tilts slightly within the nostril NO and the end effector 104 has a target area of 10 It can be appreciated that it may be possible to make full contact. However, such tilting is greatly diminished compared to such a procedure without the side support 108. Similarly, it can be appreciated that the rod 110 can tilt while the probe shaft 102 remains in place to increase the pressure on the balloon 106 and / or wall W.

  FIG. 19A illustrates an embodiment of a system 150 that guides and maintains the treatment end effector 154 laterally to assist in reaching the target area 10 along the nasal passageway CDS. In this embodiment, the system 150 includes a curved stylet or guidewire 156 and a catheter 158 that can be advanced over the guidewire 156. Catheter 158 is typically configured for cryotherapy, where balloon 160 can be filled with cryogen such that cryogenic ablation or cryomodulation into it delivers a low temperature to target area 10. , Including an inflatable sheath or balloon 160. In this embodiment, the guide wire 156 can be advanced through the patient's nostril NO along a nasal passage, such as the middle nasal passage between the lower and middle turbinates. Guidewire 156 can be pre-curved or malleable to allow curvature to be determined during the procedure. The curvature may take a variety of forms, but generally the catheter 158 that is passed therethrough is bent toward the sidewall W, such as to follow the curvature of the sac CDS. This allows the balloon 160 to be positioned relative to the sidewall W, more specifically relative to the target area 10, to treat the lower nerve N2. In addition, the curvature maintains the placement of the balloon 160 in the desired position and reduces any tendency of the balloon 160 to slide out of position during inflation and / or subsequent procedures.

  FIG. 19B illustrates a probe 170 similar to probe 20 with an end effector that includes a balloon 172. The probe 170 tilts laterally over the lower turbinate T3, below the middle turbinate T2 and into the sac CDS so that the distal end of the balloon 172 contacts the posterior surface of the target area 10 Is positioned similarly to the probe 20 described above. Once the distal portion of the probe contacts the target area 10 and the side of the middle turbinate T2 and is positioned in the sac, the balloon 172 is The remaining portion of the balloon surface area is pressed against the area 10 and expanded. Expansion occurs by pressure buildup of cryogen exhaust. This pressure can be as high as 750 psi, but will be adjusted to 10-60 psi. The expansion of the balloon 172 ranges from 0.5 to 20 mm, and perhaps from 0.7 to 10 mm. The balloon 172 can be made from a non-flexible, flexible, or semi-flexible thin wall material. In an embodiment, a semi-flexible thin wall material such as nylon or a mixture of nylon is used. The wall thickness can be less than 0.005 inches, and can be less than 0.002 inches. Dilation is created using cryogen drainage, so at the beginning of the cryogen, the balloon material adheres and prevents the balloon from freeing or moving out of the target area once treatment has begun.

  In embodiments, the end effector may include a flexible multi-part inner member that defines the outer shape of the outer film of the end effector that creates a surface area for treatment. 20A-20D show an end effector with a multi-part inner member. As shown, the inner member comprises a first member 2001 and a second member 2002 in the outer film 2004. In embodiments, it is desirable to have an end effector with a large surface area, however, the dimension of the end effector perpendicular to the longitudinal axis along the Y axis in FIGS. 20A-20D is prior to reaching the middle nasal passage. Can be a limiting factor because it must fit comfortably into the nostrils and through the narrow portion of the nasal cavity. The flexibility of the inner member is configured to bend around the rigid structure, but is sufficiently rigid to operate through the nasal cavity and compress the mucosa. In the embodiment, the first member 2001 and the second member 2002 are substantially semicircular in shape. The first member 2001 and the second member 2002 extend longitudinally away from the distal end of the shaft, then bend first away from the longitudinal axis of the shaft, and then the longitudinal axis of the shaft It may include a curvilinear portion that curves toward. The distal ends of the first member 2001 and the second member 2002 include a bend that forms an atraumatic tip and prevents damage to the patient as well as the outer film. As shown, in the y-plane, the first member 2001 and the second member 2002 form a heart shape in the expanded configuration and may have a width of 10 mm to 20 mm. In embodiments, the first member 2001 and the second member 2002 may bend toward each other and overlap each other when sufficient pressure is applied, as shown in FIGS. 5C and 5D. Configured to be able to. When overlapped, the dimension perpendicular to the longitudinal axis of the probe is reduced, for example, the dimension may be reduced within a range of 1 mm to 8 mm. When overlapped in the compression configuration, the first member 2001 and the second member 2002 form an elliptical outer shape in the y plane. The force required to overlap the first and second members 2001 and 2002 may be configured to be a force that is comfortable for the nostril to apply. When the compressed end effector enters the middle nasal passage, the first and second members are biased to return to the expanded orientation, and the end effector can be comfortably inserted through the nostril using the rigid inner member. Have a larger area. The compression feature of the inner member is achieved by having a first member 2001 and a second member 2002 formed with a gap 2002 between them in the expanded configuration shown in FIGS. 20A and 20B. . Further, as shown, the first member 2001 and the second member 2002 are offset such that they can be compressed inward toward each other or inwardly relative to each other. In an embodiment, the gap 2003 will range from 1-5 mm. The inner member can be made from a high durometer polymer such as stainless steel or nitinol wire with a diameter <0.022 inches, or nylon 6, TR55, or the like. In an embodiment, the inner member is made from stainless steel wire ranging in diameter from 0.010 to 0.020 inches. Stainless steel wire keeps the end effector center open, minimizes the possibility of ice crystals forming and causing clogging of the cryogen line, and stainless steel material properties are stable at temperatures below 0 degrees Celsius So it is ideal.

  While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims (43)

A method for treating a tissue region within a patient's nasal cavity, comprising:
Inserting a distal end of a surgical probe through the patient's nostril into the patient's nasal cavity in a first configuration, wherein the surgical probe is positioned within the outer shaft and the lumen of the outer shaft. An inner shaft that is translatable relative to the outer shaft and an end effector coupled to a distal end of the inner shaft, the distal portion of the inner shaft in the first configuration comprising: Being substantially aligned with a longitudinal axis of the outer shaft, the end effector being positioned at a first distance from a distal end of the outer shaft;
Advancing the distal end of the surgical probe into the nasal cavity using the surgical probe in the first configuration;
Translating the inner shaft relative to the outer shaft such that the surgical probe is deployed to a second configuration, wherein the end effector is spaced from the distal end of the outer shaft; and Translated laterally away from the longitudinal axis of the outer shaft to a second distance greater than the first distance, the end effector in the second configuration comprising at least one posterior nose A step positioned within the vicinity of a tissue region having nerves;
Ablating the at least one posterior nasal nerve of the tissue region with the end effector;
Including a method.   The method of claim 1, further comprising first contacting the end effector with an anatomical feature of the middle nasal passage to the sidewall of the nasal cavity prior to translating the inner shaft relative to the outer shaft. The method described.   The step of translating the inner shaft relative to the outer shaft further includes the step of translating the tissue region from a rear portion of the tissue region such that the surface of the end effector sequentially increases lateral contact with the tissue region. The method according to claim 1, comprising translating to a front part.   The first distance of the end effector from the distal end of the outer shaft ranges from less than 10 mm, and the second distance of the end effector from the distal end of the outer shaft is The method according to claim 1, which is in a range of 5 mm to 20 mm.   The method of any of claims 1-4, wherein the lateral translation of the end effector away from the longitudinal axis of the outer shaft is in the range of 10 degrees to 90 degrees.   6. The outer shaft of any of claims 1-5, wherein the outer shaft comprises an angled tip that defines an angle between the distal portion of the inner shaft and the longitudinal axis of the outer shaft in the second configuration. The method of crab.   The method of any of claims 1-6, wherein the inner shaft comprises a flexible or self-expandable material.   The inner shaft includes a bias stylet, and translating the bias stylet relative to the outer shaft includes the first being constrained by the outer shaft in a substantially linear configuration. The second configuration, wherein the stylet is not constrained by the outer shaft in a curvilinear configuration to articulate the end effector laterally away from the longitudinal axis of the outer shaft. The method according to claim 1, wherein the surgical probe is deployed.   9. The method of any of claims 1-8, further comprising maintaining the outer shaft substantially stationary relative to the nostril during the translation of the inner shaft relative to the outer shaft.   10. A method according to any preceding claim, wherein nostril extension by the outer shaft is prevented during the translation of the inner shaft relative to the outer shaft.   11. The method of any of claims 1-10, further comprising maintaining the outer shaft in an orientation substantially parallel to the patient's sagittal plane during the translation of the inner shaft relative to the outer shaft.   The end effector comprises an expandable structure coupled to the distal end of the inner shaft, and the inner member encloses the inner member such that the inner member is not attached to the interior of the expandable structure. 12. A method according to any preceding claim, disposed at the distal end of the inner shaft extending into the expandable.   Introducing cryogenic fluid into the expandable structure such that the expandable structure expands from a contracted configuration to an expanded configuration for the tissue region, the cryogenic fluid comprising the at least one posterior nasal nerve. The method of claim 12, wherein the method evaporates within the expandable structure to ablate at a low temperature.   14. The method of claim 13, further comprising maintaining the inner member relative to the interior of the expandable structure and the tissue region until the at least one posterior nasal nerve is ablated at a low temperature.   The inner member includes a first member and a second member, and the inner member includes a first member and a second member between the first member and the second member. From an expanded configuration that defines a first width of the end effector, a compressed configuration, wherein the first member and the second member define a second width of the end effector that is less than the first width. 15. A method according to any of claims 12-14, wherein the method is configurable.   The inner member is in the compressed configuration when the distal end of the surgical probe is inserted into the nostril and the end effector is positioned within the tissue region having the at least one posterior nasal nerve. The method of claim 15, wherein the extended configuration when executed.   The method of claim 15, wherein the first width is in a range of 10 mm to 20 mm.   The method of claim 17, wherein the first member and the second member do not overlap in the expanded configuration.   The method of claim 15, wherein the second width is in the range of 5 mm to 19 mm.   The method of claim 19, wherein the first member and the second member overlap in the compressed configuration.   16. The method of claim 15, wherein the first and second members comprise a heart shape in the expanded configuration and an oblong shape in the compressed configuration.   15. A method according to any of claims 12-14, wherein the inner member comprises a planar member having an elongated loop shape. A telescopic surgical probe for treating a tissue region within a patient's nasal cavity, comprising:
An elongated outer shaft having a distal end configured for insertion into a nostril of a patient's nasal cavity, the outer shaft having a longitudinal axis and a lumen therethrough;
An elongated inner shaft positioned within the lumen of the outer shaft and translatable relative to the outer shaft;
An end effector coupled to a distal end of the inner shaft, wherein a distal portion of the inner shaft is substantially aligned with the longitudinal axis of the outer shaft, the end effector comprising the surgical probe Is positioned at a first distance from the distal end of the outer shaft when the surgical probe is in a first configuration during insertion and advancement of the surgical probe into the nasal cavity, the inner shaft relative to the outer shaft. Translation translates the first distance away from the distal end of the outer shaft and laterally away from the longitudinal axis of the outer shaft when the surgical probe is in the second configuration. Configuring the end effector longitudinally to a second distance greater than, wherein the end effector in the second configuration comprises tissue having at least one posterior nasal nerve Contact band and laterally arranged to said ablate at least one after nasal nerve, and the end effector,
Comprising a probe.   24. The probe of claim 23, wherein the end effector is configured to first contact an anatomical feature of the middle nasal passage to the sidewall of the nasal cavity prior to translation of the inner shaft relative to the outer shaft. .   The end effector is configured to sequentially increase lateral contact with the tissue region from a rear portion of the tissue region to a front portion of the tissue region during translation of the inner shaft relative to the outer shaft. The probe according to claim 23 or 24.   The first distance of the end effector from the distal end of the outer shaft ranges from less than 10 mm, and the second distance of the end effector from the distal end of the outer shaft is The probe according to any one of claims 23 to 25, which is within a range of 5 mm to 20 mm.   27. A probe according to any of claims 23-26, wherein the end effector is configured to translate away from the longitudinal axis of the outer shaft within a range of 10 degrees to 90 degrees.   28. Any of claims 23-27, wherein the outer shaft comprises an angled tip that defines an angle between the distal portion of the inner shaft and the longitudinal axis of the outer shaft in the second configuration. The probe according to the above.   29. A probe according to any of claims 23-28, wherein the inner shaft comprises a flexible or self-expandable material.   The inner shaft comprises a bias stylet, the bias stylet configured to translate relative to the outer shaft, the stylet being constrained by the outer shaft in a substantially linear configuration; From the first configuration, the stylet is not constrained by the outer shaft in a curved configuration to articulate the end effector laterally away from the longitudinal axis of the outer shaft. 28. A probe according to any of claims 23-27, configured to deploy the surgical probe up to a configuration of two.   The end effector comprises an expandable structure coupled to the distal end of the inner shaft, and the inner member encloses the inner member such that the inner member is not attached to the interior of the expandable structure. 31. A probe according to any of claims 23-30, disposed at the distal end of the inner shaft extending into the expandable.   The expandable structure is configured to receive a cryogenic fluid into the expandable structure such that the expandable structure is configured to expand from a contracted configuration to an expanded configuration for the tissue region; 32. The probe of claim 31, wherein a possible structure is configured to evaporate within the expandable structure such that the cryogenic fluid ablates the at least one posterior nasal nerve at a low temperature.   The inner member includes a first member and a second member, and the inner member includes a first member and a second member between the first member and the second member. From an expanded configuration that defines a first width of the end effector, a compressed configuration, wherein the first member and the second member define a second width of the end effector that is less than the first width. 33. A probe according to any of claims 31 or 32, wherein the probe is configurable.   The inner member is in the compressed configuration when the distal end of the surgical probe is inserted into the nostril and the end effector is positioned within the tissue region having the at least one posterior nasal nerve. 34. The probe of claim 33, configured to be in the expanded configuration when   34. The probe of claim 33, wherein the first width is in the range of 10 mm to 20 mm.   36. The probe of claim 35, wherein the first member and the second member are configured not to overlap in the expanded configuration.   34. The probe of claim 33, wherein the second width is in a range of 5 mm to 19 mm.   38. The probe of claim 37, wherein the first member and the second member are configured to overlap in the compressed configuration.   34. The probe of claim 33, wherein the first and second members comprise a heart shape in the expanded configuration and an oblong shape in the compressed configuration.   33. A probe according to any of claims 31 or 32, wherein the inner member comprises a planar member having an elongated loop shape.   The end effector comprises a cryotherapy balloon, and the surgical probe is further disposed within the inner shaft, coupled with the cryogenic fluid source coupled to the inner shaft, the cryogenic fluid source and the interior of the balloon and fluid 31. A probe according to any of claims 23-30, comprising a communicating lumen.   31. A probe according to any of claims 23-30, wherein the end effector is flexibly coupled to the inner shaft.   43. A probe according to any of claims 23-42, wherein the inner shaft has a curvature or bend located at a proximal distance from the end effector, the curvature or bend being preformed.

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